Expandable bi-dimensional interbody and method of manufacturing the same

ABSTRACT

An expandable bi-dimensional intervertebral implant for an intervertebral fusion is provided. The implant includes a first hinge arm, a second hinge arm connected to the first hinge arm, and a translation member movable relative to the first hinge arm and the second hinge arm between an initial position and an engaged position. The second hinge arm is movable between a primary position and a secondary position relative to the first hinge arm. In the engaged position, the translation member biases the first hinge arm to move from a first position to a second position and biases the second hinge arm to move between a first position and a second position.

This application is a continuation of U.S. patent application Ser. No.17/559,565, filed on Dec. 22, 2021, the entire disclosure of which ishereby incorporated by reference in its entirety for all purposes.

BACKGROUND OF THE INVENTION

The subject disclosure relates generally to an implant and method forpromoting an intervertebral fusion. In particular, the subjectdisclosure relates to an expandable bi-dimensional interbody capable ofbeing inserted between adjacent vertebrae to facilitate interbody fusionof the spine.

A common procedure for handling pain associated with intravertebraldiscs that have become degenerated due to various factors such as traumaor aging is the use of intervertebral fusion devices for fusing one ormore adjacent vertebral bodies. In order to fuse adjacent vertebralbodies, the intervertebral disc must be partially or fully removed. Anintervertebral fusion device is then inserted between neighboringvertebrae to maintain normal disc spacing and restore spinal stability,thereby promoting intervertebral fusion.

Conventional fusion devices include screw and rod arrangements, solidbone implants, and fusion devices which include a cage or other implantmechanism which, typically, is packed with bone and/or bone growthinducing substances. These devices are implanted between adjacentvertebral bodies in order to fuse the vertebral bodies together toalleviate associated pain.

However, there are drawbacks associated with conventional fusiondevices. For example, typical expandable fusion cages are made ofmultiple components with many intricate mating features. Such componentsare made from subtractive manufacturing which can be time consuming tomachine each component individually and consequently becomes expensive.Moreover, solid fusion cages do not provide anterior/posteriortranslation and may be undersized or oversized during implantationcausing expulsion, creating a less than ideal fit and a poor or delayedfusion result, and/or causing subsidence into an endplate of thevertebral body. As a result, inventories of different fixed cage heightsare necessary. The above-mentioned factors result in higher market costsfor implants along with slow turnaround times and dead inventory.

Thus, there is still a need for an interbody implant capable of beingimplanted inside an intervertebral disc space that addresses theaforementioned problems of conventional fusion devices. Such a need issatisfied by the expandable bi-dimensional interbody of the subjectdisclosure.

BRIEF SUMMARY

In accordance with an exemplary embodiment, the subject disclosureprovides an expandable bi-dimensional intervertebral implant having afirst hinge arm, a second hinge arm and a translation member movablerelative to the first hinge arm and the second hinge arm between aninitial position and an engaged position. The second hinge arm isconnected to the first hinge arm and is movable between a primaryposition and a secondary position relative to the first hinge arm. Inthe engaged position, the translation member biases the first hinge armto move from a first position to a second position and biases the secondhinge arm to move between a first position and a second position.

In an aspect of the subject disclosure, the first hinge arm is a firstbifurcated hinge arm having a first arm segment and a second armsegment. The first bifurcated hinge arm includes free ends movablebetween the first position and the second position. In the firstposition, the free ends of the first bifurcated hinge arms are spacedapart a first distance and in the second position, the free ends of thefirst bifurcated hinge arms are spaced apart a second distance greaterthan the first distance. The first hinge arm includes a locking tab forlocking the first hinge arm and the second hinge arm in the secondaryposition. The first hinge arm includes a track engaging the translationmember.

In accordance with another aspect of the subject disclosure, the secondhinge arm is a second bifurcated hinge arm having a first arm segmentand a second arm segment. The second bifurcated hinge arm includes freeends movable between the first position and the second position. In thefirst position, the free ends of the second bifurcated hinge arms arespaced apart a first distance and in the second position, the free endsof the first bifurcated hinge arms are spaced apart a second distancegreater than the first distance. The translation member is positionedbetween the first and second arm segments of the first hinge arm. Thetranslation member is positioned between the first and second armsegments of the second hinge arm.

In accordance with yet another aspect of the subject disclosure, thesecond hinge arm is hingedly connected to a mid-portion of the firsthinge arm about its mid-portion. The translation member includes atranslation element and a shaft operatively engaged with the translationelement for moving the translation element between an initial positionand an engaged position. The shaft is attached to the first hinge arm ina fixed axial position. The translation element includes a cam forengaging the first and second hinge arms.

In accordance with another exemplary embodiment, the subject disclosureprovides an expandable bi-dimensional intervertebral implant having afirst bifurcated hinge arm, a second bifurcated hinge arm hingedlyconnected to the first bifurcated hinge arm, and a translation member.The first bifurcated hinge arm includes a first arm segment and a secondarm segment moveable relative to the first arm segment. The secondbifurcated hinge arm includes a first arm segment and a second armsegment moveable relative to the first arm segment. The first bifurcatedhinge arm and the second bifurcated hinge arm are movable between aprimary position and a secondary position. The translation member isbetween the first and second arm segments of the first and secondbifurcated hinge arms and movable relative to the first bifurcated hingearm and the second bifurcated hinge arm between an initial position andan engaged position. In the engaged position, a posterior end of theexpandable bi-dimensional intervertebral implant has a first height andan anterior end of the expandable bi-dimensional intervertebral implanthas a second height greater than the first height. In the engagedposition, the translation member splays first and second bifurcatedhinge arms.

The subject disclosure further provides a method of manufacturing anexpandable bi-dimensional intervertebral implant having the step ofadditively manufacturing the expandable bi-dimensional intervertebralimplant of the subject disclosure as a fully assembled component. Eachcomponent of the expandable bi-dimensional intervertebral implant isadditively manufactured with successive layers of material substantiallyparallel to a superior face of the first hinge arm.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofthe exemplary embodiments of the subject disclosure, will be betterunderstood when read in conjunction with the appended drawings. For thepurpose of illustrating the subject disclosure, there are shown in thedrawings exemplary embodiments. It should be understood, however, thatthe exemplary embodiments of the subject disclosure are not limited tothe precise arrangements and instrumentalities shown.

In the drawings:

FIG. 1 is a perspective view of an expandable bi-dimensionalintervertebral implant in accordance with an exemplary embodiment of thesubject disclosure in a collapsed or primary position;

FIG. 2 is a perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 in a secondary position;

FIG. 3 is a perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 2 with the first and second bifurcatedhinge arms in a second or expanded position;

FIG. 4 is an exploded, perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 ;

FIG. 5 is a side cross-sectional perspective view of the expandablebi-dimensional intervertebral implant of FIG. 1 in the collapsed orprimary position;

FIG. 6A is a top view of the expandable bi-dimensional intervertebralimplant of FIG. 1 in the collapsed or primary position;

FIG. 6B is a rear view of the expandable bi-dimensional intervertebralimplant of FIG. 1 in the collapsed or primary position;

FIG. 7 is a top view of the expandable bi-dimensional intervertebralimplant of FIG. 1 in the secondary position;

FIG. 8A is a top view of the expandable bi-dimensional intervertebralimplant of FIG. 1 in the collapsed or primary position with an expansioninstrument;

FIG. 8B is a top view of the expandable bi-dimensional intervertebralimplant of FIG. 1 in the secondary position with an expansioninstrument;

FIG. 9 is a side perspective view of a first hinge arm of the expandablebi-dimensional intervertebral implant of FIG. 1 ;

FIG. 10 is a top view of the first hinge arm of the expandablebi-dimensional intervertebral implant of FIG. 1 ;

FIG. 11 is a top cross-sectional view of the expandable bi-dimensionalintervertebral implant of FIG. 1 ;

FIG. 12 is a side perspective view of a translation element for engagingthe first hinge arm of the expandable bi-dimensional intervertebralimplant of FIG. 1 ;

FIG. 13A is a side perspective view of a second hinge arm of theexpandable bi-dimensional intervertebral implant of FIG. 1 in a firstposition;

FIG. 13B is a side perspective view of a second hinge arm of theexpandable bi-dimensional intervertebral implant of FIG. 1 in a secondor expanded position;

FIG. 14 is a bottom view of a translation element of the translationmember of the expandable bi-dimensional intervertebral implant of FIG. 1;

FIG. 15A is a side perspective view of a shaft of the translation memberof the expandable bi-dimensional intervertebral implant of FIG. 1 ;

FIG. 15B is a perspective view of a shaft of the translation member ofthe expandable bi-dimensional intervertebral implant of FIG. 1 ;

FIG. 16 is a perspective view of the translation member of theexpandable bi-dimensional intervertebral implant of FIG. 1 ;

FIG. 17 is a side perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 in a secondary position;

FIG. 18 is another side perspective view of the expandablebi-dimensional intervertebral implant of FIG. 1 in a secondary position;

FIG. 19 is a side perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 in a secondary position and with thefirst and second bifurcated hinge arms in a second or expanded position;

FIG. 20 is a front perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 with the first and second bifurcatedhinge arms in a second or expanded position;

FIG. 21 is a side perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 with the first and second bifurcatedhinge arms in a second or expanded position;

FIG. 22A is a side perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 illustrating the implant with a planarsurface;

FIG. 22B is a side perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 illustrating the implant with a curvedsurface;

FIG. 23A is a top view of the expandable bi-dimensional intervertebralimplant of FIG. 1 in the collapsed or primary position;

FIG. 23B is a top view of the expandable bi-dimensional intervertebralimplant of FIG. 1 in the secondary position;

FIG. 24A is a side perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 in the collapsed or primary position;

FIG. 24B is a side perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 with the first and second bifurcatedhinge arms in a second or expanded position;

FIGS. 25A-D are top perspective views of various insertion trajectoriesapplicable for use during implantation of the expandable bi-dimensionalintervertebral implant of the subject disclosure;

FIGS. 26A-D are top perspective views of the expandable bi-dimensionalintervertebral implants illustrated in FIGS. 25A-D with the first andsecond bifurcated hinge arms in a second or expanded position;

FIG. 27 is an isolated side view of a variable density external surfaceof the expandable bi-dimensional intervertebral implant of FIG. 1 ;

FIG. 28 is an isolated side view of a variable textured teethed zone ofthe expandable bi-dimensional intervertebral implant of FIG. 1 ;

FIG. 29 is an isolated top view of a textured surface of the expandablebi-dimensional intervertebral implant of FIG. 1 ;

FIGS. 30A-E are perspective views of various footprints of interbodyfusion devices applicable for use with the subject disclosure; and

FIG. 31 is a perspective view of the expandable bi-dimensionalintervertebral implant of FIG. 1 with lines depicting the layers formedby additive manufacturing of the implant.

DETAILED DESCRIPTION OF THE INVENTION

Reference will now be made in detail to the exemplary embodiments of thesubject disclosure illustrated in the accompanying drawings. Whereverpossible, the same or like reference numbers will be used throughout thedrawings to refer to the same or like features. It should be noted thatthe drawings are in simplified form and are not drawn to precise scale.Certain terminology is used in the following description for convenienceonly and is not limiting. Directional terms such as top, bottom, left,right, above, below and diagonal, are used with respect to theaccompanying drawings. The term “distal” shall mean away from the centerof a body. The term “proximal” shall mean closer towards the center of abody and/or away from the “distal” end. The words “inwardly” and“outwardly” refer to directions toward and away from, respectively, thegeometric center of the identified element and designated parts thereof.Such directional terms used in conjunction with the followingdescription of the drawings should not be construed to limit the scopeof the subject disclosure in any manner not explicitly set forth.Additionally, the term “a,” as used in the specification, means “atleast one.” The terminology includes the words above specificallymentioned, derivatives thereof, and words of similar import.

“About” as used herein when referring to a measurable value such as anamount, a temporal duration, and the like, is meant to encompassvariations of ±20%, ±10%, ±5%, ±1%, or ±0.1% from the specified value,as such variations are appropriate.

“Substantially” as used herein shall mean considerable in extent,largely but not wholly that which is specified, or an appropriatevariation therefrom as is acceptable within the field of art.“Exemplary” as used herein shall mean serving as an example.

Throughout this disclosure, various aspects of the exemplary embodimentscan be presented in a range format. It should be understood that thedescription in range format is merely for convenience and brevity andshould not be construed as an inflexible limitation on the scope of theexemplary embodiments. Accordingly, the description of a range should beconsidered to have specifically disclosed all the possible subranges aswell as individual numerical values within that range. For example,description of a range such as from 1 to 6 should be considered to havespecifically disclosed subranges such as from 1 to 3, from 1 to 4, from1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well asindividual numbers within that range, for example, 1, 2, 2.7, 3, 4, 5,5.3, and 6. This applies regardless of the breadth of the range.

Furthermore, the described features, advantages and characteristics ofthe exemplary embodiments may be combined in any suitable manner in oneor more embodiments. One skilled in the relevant art will recognize, inlight of the description herein, that the exemplary embodiments can bepracticed without one or more of the specific features or advantages ofa particular embodiment. In other instances, additional features andadvantages may be recognized in certain embodiments that may not bepresent in all embodiments of the subject disclosure.

Referring to FIGS. 1-4 , there is shown an exemplary embodiment of anexpandable bi-dimensional intervertebral implant 100 in accordance withthe subject disclosure. As shown in FIG. 4 , the intervertebral implant100 includes a first hinge arm 110, a second hinge arm 120 pivotablyconnected to the first hinge arm, and a translation member 130 movablerelative to the first hinge arm and the second hinge arm. In general,the translation member 130 biases the first hinge arm 110 and the secondhinge arm 120. As further discussed below, the translation member 130includes a translation element 140 and a shaft 150 operatively engagedwith the translation element 140.

The expandable bi-dimensional intervertebral implant 100 can bemanufactured from a number of materials including metals e.g., titanium,stainless steel, titanium alloys, non-titanium metallic alloys,polymers, e.g., high-density polyethylene, and polyetheretherketone(PEEK), and ceramics e.g., silicon nitride (Si₃N₄), zirconium oxide(ZrO₂), and silver oxide (Ag₂O), and other suitable materials, bothradiopaque and radiolucent. The expandable bi-dimensional intervertebralimplant 100 can be manufactured from more than one material. In someexemplary embodiments, the expandable bi-dimensional intervertebralimplant 100 is made from a primary base material and a secondary elementsuch that the implant 100 can be made from at least about 51% of theprimary base material and from about 0% to about 49% of the secondaryelement. In other embodiments, an expandable bi-dimensionalintervertebral implant 100 can be manufactured from multiple materialsby integrating the secondary element within the primary base materialand/or by coating a surface of the primary base material with thesecondary element.

Advantageously, ceramics such as silicon nitride produce alkalinecompounds that are lethal to bacteria and promote osteo-integration. SeePezzotti, G. et al. Silicon Nitride Bioceramics Induce Chemically DrivenLysis in Porphyromonas gingivalis. Langmuir 32, 3024-3035 (2016) andWebster, T J et al. “Anti-infective and osteointegration properties ofsilicon nitride, poly(ether ether ketone), and titanium implants.” Actabiomaterialia vol. 8,12 (2012): 4447-54. Additionally, silicon nitridehas osteoinductive, osteoconductive, hydrophilic, and/or germicidalsurface properties that promote bone formation and tissue development.Silicon nitride is also inherently resistant to bacteria and biofilmformation. See e.g., Ishikawa, Masahiro et al. “Surface topography ofsilicon nitride affects antimicrobial and osseointegrative properties oftibial implants in a murine model.” Journal of biomedical materialsresearch. Part A vol. 105, 12 (2017): 3413-3421.doi:10.1002/jbm.a.36189.

As oriented in FIGS. 1, 2, 3, 6A, 6B, 7, 8A and 8B, the second hinge arm120 is movable between a primary position (FIGS. 1, 6A, 6B and 8A) and asecondary position (FIGS. 2, 3, 7 and 8B) relative to the first hingearm 110.

As shown in FIGS. 1-4 and 9 , the first hinge arm 110 includes ananterior end 191 and a posterior end 192. The anterior end 191 of thefirst hinge arm 110 is configured as a first bifurcated hinge arm havinga first arm segment 112 and a second arm segment 114. The first andsecond arm segments 112, 114 extend from a base 113 about the posteriorend 192 of the first hinge arm 110. As shown in FIG. 9 , the first hingearm 110 includes a through hole 118 about its posterior end 192 forreceiving the shaft 150 of the translation member 130 therethrough. Thethrough hole 118 is a posterior facing through hole and is located aboutthe posterior end 192 of the first hinge arm 110. The through hole 118contains threads 117 along its inner surface for engaging correspondingthreads on the translation member 130. A longitudinal axis of thethrough hole 118 extends in the same direction as a longitudinal axis orextent of the translation member 130. The posterior end 192 of the firsthinge arm 110 further includes external threads 111 about its outersurface for engaging a drive instrument interface (not shown). The firsthinge arm 110 further includes an upper surface 193, a lower surface 194and a through hole 195 that passes between the upper surface 193 and thelower surface 194. The through hole has a central longitudinal axistransverse to the direction of the longitudinal axis of the first hingearm 110.

The first hinge arm 110 also includes an inner cavity 161 between theupper surface 193 and lower surface 194 for mountably receiving andretaining the shaft 150 of the translation member 130. There is a flange159 adjacent a posterior end of the cavity 161 which serves as a stop orlimit for limiting movement of the shaft 150 therein.

The through hole 195, in an exemplary embodiment, is sized to receivebone graft or similar bone growth inducing material to be packed in acenter of the implant 100. In other words, the through hole 195 can beconfigured to enable bone graft material deposited within the implant100 to engage, contact and/or fuse with an adjacent vertebral body. Theupper surface 193 may be referred to as an outer surface and/or asuperior surface. Similarly, the lower surface 194 may be referred to asan inner surface and/or an inferior surface.

As shown in FIG. 10 , the upper surface 193 of the first hinge arm 110is generally planar to allow the upper surface 193 of the first hingearm 110 to engage with adjacent vertebral bodies. However, as shown inFIG. 22B, the upper surface 193 and/or lateral surfaces of the firsthinge arm can be curved convexly or concavely to allow for a greater orlesser degree of engagement with adjacent vertebral bodies. It is alsocontemplated that the upper surface 193 and/or lateral surfaces of thefirst hinge arm can be generally planar (FIG. 22A) but include agenerally straight ramped surface or a curved ramp surface to allow forengagement with adjacent vertebral bodies in a lordotic fashion. In anexemplary aspect, the first hinge arm 110 is configured having asubstantially trapezoidal-shaped posterior profile, as shown in FIG. 6B.However, the posterior profile of the first hinge arm 110 can beconfigured as any shape suitable for the foregoing intended use and/ordesign criteria, e.g., substantially rectangular, triangular and thelike.

In an aspect of the exemplary embodiment, the first hinge arm 110includes texturing 119 along its outer surfaces to aid in grippingadjacent vertebral bodies during implantation of the implant 100. Asshown in FIG. 9 , the texturing 119 can be positioned on outer surfacesof the first arm segment 112 and the second arm segment 114. As shown inFIGS. 27-29 , it is to be understood that the texturing 119 can be avariable density external surface (FIG. 27 ) or a variable texturedteethed zone (FIG. 28 ). The variable density external surface can bedeveloped using a topology optimization method and/or algorithm tocreate a lightweight bi-dimensional intervertebral implant having adesired variable feel or firmness and/or shape retention in one regionof the implant relative to another region of the implant. Such topologyoptimization can be utilized to customize implants based on the needs ofa particular patient. The texturing can include, but is not limited to,teeth, ridges, friction increasing elements, patterned divots, throughholes, keels or gripping or purchasing projections. As shown in FIGS. 27and 28 , the texturing can be a multi-density and/or variable texturedteethed zone having a height Y1 with a trabecular zone having a heightY2.

The variable density external surface is achieved by controlling thevolume to porosity ratio of the subject external surface. For example,the malleability/deformability of the surface can be achieved bydecreasing the volumetric density (i.e., increasing porosity) and bydecreasing the thickness of the external surface layer. This can beaccomplished through various techniques including, but not limited to,additive manufacturing, subtractive manufacturing, chemical subtraction,laser texturing, and the like. Such methods are disclosed, for example,in U.S. Pat. Nos. 10,596,660 and 10,864,070, the disclosures of whichare hereby incorporated by reference in their entirety for all purposes.

Referring now to FIGS. 4 and 12 , the first hinge arm 110 furtherincludes one or more mating elements, e.g., a pair of anterior maletracks 170. The anterior male track 170 operatively engages withcomplementary or corresponding mating elements on the translation member130 to form a slidable joint. That is, the translation member 130 isconfigured to slideably engage the first hinge arm 110. The slideablejoint advantageously enables the first hinge arm 110 to move from afirst position to a second position. As further discussed below, theanterior male track 170 prevents dislocation of the translation member130 when the implant 100 is assembled.

As shown in FIGS. 1-4 , the first hinge arm 110 further includes aradial hinge, e.g., radial protrusion 116 on each of its upper and lowersurfaces. Specifically, the radial protrusion 116 is located about amid-portion 115 of the first hinge arm 110. As further discussed below,the radial protrusion 116 of the first hinge arm 110 operatively engagesthe second hinge arm 120 when the first hinge arm 110 engages the secondhinge arm 120.

Referring now to FIGS. 9 and 10 , the first hinge arm 110 includes alocking tab 160 for securing the first hinge arm 110 and the secondhinge arm 120 in a secondary position. While the discussion below refersto the locking tab 160 in the singular, it is to be understood that thefirst arm segment 112 and the second arm segment 114 each includerespective locking tabs (FIG. 9 ). Specifically, as further discussedbelow, the locking tab 160 projects laterally away from the first hingearm 110 and is received within a recess 171 of the second hinge arm 120(FIG. 11 ). Additionally, when the implant 100 is assembled, there is agap 188 (FIG. 18 ) formed between the first arm segment 112 and thesecond arm segment 114. The gap 188 slideably receives a cooperatingtrack 181 on the translation element 140. The track 181 is configured asshown in FIG. 18 , e.g., as a tongue. However, it can be configured asany other suitable element including, but not limited to, a ridge, toothor projection.

As shown in FIGS. 1-4 and 13A, the second hinge arm 120 includes ananterior end 131 and a posterior end 132 and is pivotably connected tothe first hinge arm 110. The second hinge arm 120 further includes anupper surface 133 and a lower surface 134. The posterior end 132 isconfigured as a second bifurcated hinge arm having a first arm segment122 and a second arm segment 124. The first and second arm segments 122,124 extend from a base 121 about the anterior end 131 of the secondhinge arm 120. In accordance with an aspect, the base 121 about theanterior end 131 is of unitary construction. As shown in FIGS. 4 and13A, the second hinge arm 120 includes a through hole 126 about itsmid-portion 125 extending in a direction transverse to its longitudinalaxis for receiving respective radial protrusions 116 of the first hingearm 110.

As shown in FIGS. 8A and 8B and further discussed below, a moving shaft187 of a driving tool 185 is used to move the second hinge arm 120 fromthe primary position to the secondary position relative to the firsthinge arm 110. Specifically, the second hinge arm 120 is rotatedapproximately ninety degrees such that its longitudinal axis issubstantially perpendicular to a longitudinal axis of the first hingearm 110 in the secondary position. The second hinge arm 120 is securedin the secondary position via the locking tab 160.

In an aspect of the exemplary embodiment, the second hinge arm 120includes texturing 127 to aid in gripping adjacent vertebral bodies. Thetexturing 127 can be the same or similar texturing as described abovefor the first hinge arm 110. That is, similar to the texturing 119 ofthe first hinge arm 110, the texturing 127 can be a variable densityexternal surface or a variable textured teethed zone.

Referring back to FIGS. 1-3 and 13A, the first arm segment 122 andsecond arm segment 124 form a rounded or concave recess 129 (FIG. 2 )about the posterior end 132 of the second hinge arm 120 that iscomplementary shaped to the shaft 150 of the translation member 130 suchthat the shaft 150 is slidable along the second hinge arm 120 in thecollapsed position. Additionally, as shown in FIGS. 13A, 17 and 18 , theanterior end 131 of the second hinge arm 120 includes a recess 184formed by its first and second arm segments 122, 124 for enclosing alateral portion 182 (FIG. 16 ) of the translation element 140 in thecollapsed position. The anterior end 131 of the second hinge arm 120also includes a channel 183 complementary in shape to the cooperatingtrack 181 on the translation element 140.

In accordance with an exemplary embodiment, at least one of the firsthinge arm 110 and second hinge arm 120 comprises silicon nitride.Alternatively, both the first and second hinge arms can comprise siliconnitride, partially or fully. As previously discussed above, at least oneof the first hinge arm 110 and second hinge arm 120 includes a variabledensity external surface and/or a variable textured teethed zone. Thatis, one or both the first and second hinge arms can comprise variabledensity external surfaces and/or variable textured teethed zones.

As shown in FIGS. 1-5 and 14-16 , the translation member 130 includes atranslation element 140 and a shaft 150 operatively engaged with thetranslation element 140 for moving the translation element 140 betweenan initial position and an engaged position. The translation member 130can be formed from materials that contain osteoinductive,osteoconductive, and/or germicidal surface properties for promoting boneformation and tissue development, e.g., ceramics such as siliconnitride, zirconium oxide, silver oxide, and other suitable materials,and can also be formed from radiopaque or radiolucent materials suchthat the spacing between the first and second hinge arms can be visibleon radiographs e.g., a polymer such as high-density polyethylene orpolyetheretherketone (PEEK). In general, the translation member 130 ispositioned between the first and second arm segments 112, 114 of thefirst hinge arm 110, and between the first and second arm segments 122,124 of the second hinge arm 120.

The shaft 150 includes a head 152 and a body 155. The head 152 of theshaft 150 includes a mating feature or drive 156 for engaging thedriving tool 185 (FIGS. 8A-B). The head 152 includes a threaded portion154 having a larger diameter than a diameter of the body 155 so as toengage the flange 159 of the first hinge arm 110. The body 155 of theshaft 150 contains threads 158 along its inner surface for engaging thetranslation element 140.

Referring back to FIGS. 1-4 and 9 , the shaft 150 is mounted within thefirst hinge arm 110 substantially flush with a posterior face of thefirst hinge arm. Specifically, the first hinge arm 110 includes theinner cavity 161 for mountably receiving the shaft 150 including thehead 152 therein. Thus, when the shaft 150 is positioned within thecavity 161, the head 152 is substantially flush with the posterior faceof the first hinge arm 110. When the implant is in a fully assembledconfiguration, the shaft 150 is attached to the first hinge arm 110 in afixed axial position relative to the first hinge arm such that arotational force applied by the driving tool 185 to the shaft results intranslation of the translation element 140 between an initial positionand an engaged position relative to the shaft and first hinge arm. Thatis, the translation element 140 translates toward the shaft 150 as thetranslation element moves from the initial position towards the engagedposition.

The translation element 140 is configured as best shown in FIGS. 4, 5,12, 14 and 16-18 , and includes a threaded shaft 144 and a cam 180. Aterminal end of the threaded shaft 144 is e.g., concave in shape, forexample, a concave distal end or a distally facing concave end, but mayalternatively be a convex or rounded end. As shown in FIGS. 15A, 15B,and 16 , the threaded shaft 144 of the translation element 140 engagesthe inner threads 158 of the shaft 150. The translation element 140 alsoincludes a cooperating retention track 172 along the threaded shaft 144of the translation element 140 for operatively engaging correspondingmale tracks 170 of the first hinge arm 110 to form a slidable joint. Theslidable joint prevents dislocation of the translation member 130 as itengages the first hinge arm 110 during implantation of the implant 100as well as rotation of the translation member upon rotation of theshaft. Preferably, the translation element includes a pair ofcooperating retention tracks along opposite sides of the threaded shaft.

As shown in FIG. 5 , the anterior end of the translation element 140includes a detent 146 for operatively engaging the second hinge arm 120at a predetermined location when in the primary position. That is, thedetent 146 extends proud of the anteriorly facing end and is sized andshaped to be received within a recess 128 of the second hinge arm 120.The detent 146 can also alternatively be formed of various otherconfigurations that allow it to properly engage the recess 128 of thesecond hinge arm 120, such as being nipple shaped, dome shaped, or anyother detent configuration suitable for the foregoing intended use. Thedetent 146 is pressed into the recess 128 and secures the second hingearm 120 in the primary position to prevent expansion of the implant 100during implantation into the patient. In sum, the detent 146 preventsthe second hinge arm 120 from breaking out prematurely duringimplantation.

As shown in FIGS. 14 and 16-21 , the cam 180 includes a camming head 180that is configured as a substantially trapezoidal shaped cam having anupper camming surface and a lower camming surface. The cam 180 furtherincludes the T-shaped track 181 along its medial side that iscomplementary shaped to the gap 188 formed between the first arm segment112 and the second arm segment 114 of the first hinge arm 110. The gap188 slideably receives the T-shaped track 181 when the translationmember moves toward the engaged position. As the translation member 130is translated towards the engaged position, the camming head biases thefirst arm segment 112 and the second arm segment 114 of first hinge arm110 outwardly or away from each other to move the first hinge arm 110from the first position to the second position, i.e., an expandedposition. Similarly, the biasing force from the camming head causes thefirst arm segment 112 and the second arm segment 114 of the first hingearm 110 to bias the respective first arm segment 122 and second armsegment 124 of the second hinge arm 120 outwardly or away from eachother to move the second hinge arm from the first position to secondposition, i.e., an expanded position (FIG. 19 ).

In sum, the cam 180 of the translation element 140 engages the first andsecond hinge arms 110, 120. That is, as the cam 180 translates towardthe shaft 150, the cam biases the first hinge arm 110 to move from afirst position to a second position and biases the second hinge arm 120to move between a first position and a second position. In other words,the cam 180 of the translation member 130 splays the first and secondhinge arms 110, 120. The expandable bi-dimensional intervertebralimplant 100 can advantageously transition between a fully collapsedposition (FIG. 1 ), a secondary position (FIG. 2 ), and an engaged orexpanded position (FIG. 3 ).

In an aspect of the exemplary embodiment, the first hinge arm 110includes free ends 106A-B movable between the first position and thesecond position. In the first position (FIG. 2 ), the free ends 106A-Bof the first hinge arm segments 112, 114 are spaced apart a firstdistance α1. In the second position (FIG. 3 ), the free ends 106A-B arespaced apart a second distance α2 greater than the first distance α1.Similar to the first hinge arm 110, the second hinge arm 120 includesfree ends 123A-B movable between the first position and the secondposition, when in the secondary position. In the first position (FIG. 2), the free ends 123A-B of the second hinge arm segments 122, 124 arespaced apart a first distance β1. In the second position (FIG. 3 ), thefree ends 123A-B are spaced apart a second distance β2 greater than thefirst distance β1. As shown in FIG. 19 , in the engaged position, aposterior end 102 of the expandable bi-dimensional intervertebralimplant 100 has a first height H1 and an anterior end 104 of the implanthas a second height H2 greater than the first height H1. The secondheight H2 can vary e.g., it can range from about 0 mm to 10 mm. Theheight varies depending upon the amount of splaying as the translationmember 130 moves along the corresponding male tracks 170 to splay therespective segments of first and second hinge arms 110, 120. In otherwords, the expandable bi-dimensional intervertebral implant provides forvariable adjustment of the amount of asymmetrical expansion. Inaccordance with an aspect shown in FIGS. 3 and 13B, the first and secondarm segments 122, 124 of the second hinge arm 120 are tapered to allowfor splaying without interference.

With reference to FIGS. 1-4 and 9 , the expandable bi-dimensionalintervertebral implant 100 is assembled in a modular fashion. The firsthinge arm 110 and second hinge arm 120 are pivotably or hingedlyconnected. Specifically, the pair of radial protrusions 116 on each ofthe upper and lower surfaces around mid-portion 115 of the first hingearm 110 operatively engage respective through holes 126 on each of theupper and lower arm segments around mid-portion 125 of the second hingearm 120. Thereafter, the shaft 150 of the translation member 130 ismounted within the cavity 161 of the first hinge arm 110. As shown inFIGS. 12 and 14-16 , the threaded shaft 144 of the translation element140 engages the inner threads 158 of the shaft 150. As the translationelement 140 engages the inner threads 158, the anterior male tracks 170of the first hinge arm 110 slideably engage the cooperating retentiontracks 172 on the threaded shaft 144 of the translation element 140 toform a slidable joint.

Referring now to FIGS. 8A and 8B, the driving tool 185 having a fixedshaft 186 and moving shaft 187 is used to expand the implant 100 whenimplanted in the body. The fixed shaft 186 is rotatably connected to themating feature 156 on the head 152 of the shaft 150. A force applied onthe moving shaft 187 causes the moving shaft to bias the second hingearm 120 from the primary position (FIG. 8A) to the secondary position(FIG. 8B). In doing so, the second hinge arm 120 is rotatedapproximately ninety degrees such that its longitudinal axis issubstantially perpendicular to a longitudinal axis of the first hingearm 110. As shown in FIG. 11 , the second hinge arm 120 is secured inposition by the locking tab 160 of the first hinge arm 110. That is, thelocking tab 160 is received within the recess 171 of the second hingearm 120 to prevent the second hinge arm from rotating back to theprimary position or away from the secondary position.

Referring now to FIGS. 3, 8A-8B, 11, 15A, 15B, 16 and 19 , a rotationalforce applied on the head 152 of the shaft 150 for example via a torquetool applied to the mating feature 156, causes the threaded shaft 144 ofthe translation element 140 to engage the inner threads 158 of theshaft. As the translation element 140 engages the inner threads 158, theanterior male tracks 170 of the first hinge arm 110 slideably engage thecooperating retention tracks 172 on the threaded shaft 144 of thetranslation element 140. As a result, the translation element 140translates toward the shaft 150 as the translation member moves from theinitial position towards the engaged position.

As the translation member 130 is translated towards the engagedposition, the cam 180 biases the first arm segment 112 and the secondarm segment 114 of first hinge arm 110 outwardly to move the first hingearm 110 from the first position to the second position. As a result, thefirst and second arm segments 112, 114 bias the first and second armsegments 122, 124 of the second hinge arm outwardly to move the secondhinge arm from the first position to the second position.

Referring now to FIGS. 2-4 , in the first position (FIG. 2 ), ananterior end of the translation member 130 is anteriorly spaced adistance X1 from the anterior end 191 of the first hinge arm 110. In thesecond position (FIG. 3 ), the anterior end of the translation member130 is posteriorly spaced a distance X2 from the anterior end 191 of thefirst hinge arm 110. As the translation member moves posteriorly, thespace between the free ends 106A-B of the first hinge arm 110 increases(α1→α2). Similarly, the space between the free ends 123A-B of the secondhinge arm 120 increases (β1→β2).

In some exemplary embodiments, the second distance α2 can be from about25% to 100% greater than the first distance α1, including 20, 30, 40,50, 60, 70, 80 and 90%. In other exemplary embodiments, the seconddistance α2 can be from about 50% to 100% greater than the firstdistance α1. In other embodiments, the second distance α2 can be from atleast about 50% greater than the first distance α1. For example, thesecond distance α2 can be about 4 mm to 6 mm including 4.5, 5, and 5.5mm greater than the first distance α1, but also less than 4 mm andgreater than 6 mm. Similarly, in some exemplary embodiments, the seconddistance β2 can be from about 25% to 100% greater than the firstdistance β1, including 20, 30, 40, 50, 60, 70, 80 and 90%. In otherexemplary embodiments, the second distance β2 can be from about 50% to100% greater than the first distance β1. In other embodiments, thesecond distance β2 can be from at least about 50% greater than the firstdistance β1. For example, the second distance β2 can be about 4 mm to 6mm including 4.5, 5, and 5.5 mm greater than the first distance β1, butalso less than 4 mm and greater than 6 mm. Generally, the change indistance is caused by movement of the translation member from theinitial position towards the engaged position. Those skilled in the artmay appreciate that, in use, the distance between the free ends 106A-Bof the first hinge arm and the distance between the free ends 123A-B ofthe second hinge arm can be respectively adjusted to accommodate anindividual patient's needs.

In the second position, the implant 100 achieves a lordotic angularexpansion. As shown in FIGS. 3, 20 and 21 , in the second position(i.e., expanded position), the free ends 106A-B of the first hinge arm110 are spaced apart distance α2 and create an angle A1 (FIG. 21 )between a longitudinally extending axis of the first arm segment 112 anda longitudinally extending axis of the second arm segment 114. In someexemplary embodiments, the angle A1 can be from about 0 to 30 degrees.Similarly, the free ends 123A-B of the second hinge arm 120 are spacedapart distance β2 and create an angle B1 (FIG. 20 ) between alongitudinally extending axis of the first arm segment 122 and alongitudinally extending axis of the second arm segment 124. Similarly,in some exemplary embodiments, the angle B1 can be from about 0 to 30degrees. As such, the overall implant achieves an asymmetric overallexpansion or in other words a substantially trapezoidal profile capableof lordotic angular expansion of the spine. After implantation in thebody of a patient, the implant can transition between a fully collapsedposition (FIGS. 23A and 24A) to an engaged position with lordoticangular expansion (FIGS. 23B and 24B).

While the subject disclosure discusses an exemplary embodiment of anexpandable bi-dimensional intervertebral implant, the expandablebi-dimensional intervertebral implants discussed herein can be used withor in combination with various other interbody fusion devices such asthose shown in FIGS. 30A-30E having various footprints including, butnot limited to, transforaminal lumbar interbody fusion (TLIF), directlateral interbody fusion (DLIF), and oblique lumbar interbody fusion(OLIF). Moreover, the expandable bi-dimensional intervertebral implantdescribed herein can be used with a secondary cage that can be a TLIF,DLIF, or OLIF device. Such cages are disclosed e.g., in U.S. Pat. Nos.10,543,101 and 10,219,912, the disclosures of which are herebyincorporated by reference in their entirety for all purposes.

Referring now to FIGS. 25A-25D, the expandable bi-dimensionalintervertebral implant 100 discussed herein can be implanted into thebody of a patient at several different trajectories based on anindividual patient's needs. During implantation, the implant 100 is inthe collapsed position. Referring now to FIGS. 26A-26D, afterimplantation into the body, the implant 100 can be moved from thecollapsed position to the engaged position. As shown in FIGS. 25B and26B, the expandable bi-dimensional intervertebral implant describedherein can be used with a secondary expandable bi-dimensionalintervertebral implant.

The subject disclosure also provides a method of manufacturing anexpandable bi-dimensional intervertebral implant. The method includescreating a computer aided design (CAD) model of a fully assembledimplant. The method further includes the step of additivelymanufacturing the implant based on the CAD implant model with successivelayers of material substantially parallel to a superior face of thefirst hinge arm. Advantageously, the layers being substantially parallelprovides increased yield strength to the implant when normal loads areapplied.

In contrast, if the additive layers extend in a direction in line withforces normal to a longitudinal length of the implant, the expandablebi-dimensional intervertebral implant will sheer more easily and havelower yield and compressive strength. However, if the additivelymanufactured layers extend at an angle relative to a longitudinal lengthof the implant, the line of forces acting on the implant will betransverse to the additive layers, thereby reducing the likelihood ofsheering of the implant by increasing the parts' yield and compressivestrength.

Additionally, additive manufacturing advantageously allows theexpandable bi-dimensional intervertebral implant to be formed as asingle integral piece and constructed layer-by-layer, bottom-to-top,such that the components are integrally connected. In additivemanufacturing, various types of materials in powder, liquid or granularform are deposited in layers. For additive manufacturing, a slopedsurface on the radial protrusion 116 is required due to layer stackingand the orientation of the implant during 3D printing. That is, a slopedsurface on the radial protrusion 116 avoids undesirable issuesassociated with the presence of overhangs in 3D printing such ascurling, sagging, delamination, or collapsing. Utilizing a slope ensuresthat each new layer has enough support to remain intact and make 3Dprinting possible. As shown in FIG. 31 , the deposited layers can becured layer by layer until the entire component is complete. Forexample, an energized beam can be scanned over a bath of material tosolidify a precise pattern of the material to form each layer until theentire component is complete. Similar techniques include, but are notlimited to, rapid manufacturing, layered manufacturing, rapidprototyping, laser sintering, and electron beam melting. Such methods ofadditive manufacturing are generally disclosed in U.S. Pat. Nos.9,783,718 and 10,596,660, the disclosures of which are herebyincorporated by reference in their entirety for all purposes.

It will be appreciated by those skilled in the art that changes could bemade to the exemplary embodiments described above without departing fromthe broad inventive concept thereof. It is to be understood, therefore,that the subject disclosure is not limited to the particular exemplaryembodiments disclosed, but it is intended to cover modifications withinthe spirit and scope of the subject disclosure as defined by theappended claims.

I/We claim:
 1. An expandable bi-dimensional intervertebral implantcomprising: a first hinge arm; a second hinge arm connected to the firsthinge arm; and a translation member that includes a shaft and a cam forbiasing one of the first and second hinge arms in two directions.
 2. Theexpandable bi-dimensional intervertebral implant of claim 1, wherein thecam includes opposing cam surfaces for biasing one of the first andsecond hinge arms in opposite directions.
 3. The expandablebi-dimensional intervertebral implant of claim 1, wherein the camincludes opposing cam surfaces for biasing one of the first and secondhinge arms in the superior and inferior directions.
 4. The expandablebi-dimensional intervertebral implant of claim 1, wherein the camincludes a superior cam surface and an inferior cam surface.
 5. Theexpandable bi-dimensional intervertebral implant of claim 1, wherein theshaft is integrally connected with the cam.
 6. The expandablebi-dimensional intervertebral implant of claim 1, wherein the shaft is athreaded shaft fixedly connected to the cam.
 7. The expandablebi-dimensional intervertebral implant of claim 1, wherein thetranslation member biases the first hinge arm and the second hinge arm.8. The expandable bi-dimensional intervertebral implant of claim 1,wherein the translation member biases the first hinge arm and the secondhinge arm in opposite directions.
 9. The expandable bi-dimensionalintervertebral implant of claim 1, wherein the translation member ispositioned to bias the first hinge arm about its midportion.
 10. Theexpandable bi-dimensional intervertebral implant of claim 1, wherein thefirst hinge arm is connected to the second hinge arm about theirrespective midportions.